Flow Reduction Catheter for Fluid Overload Treatment

Abstract

Disclosed herein is a vessel shaping device configured to reshape a vessel along a single axis and regulate a blood flow therethrough. The vessel reshaping device generally consists of a frame that can transition to an expanded configuration and can temporarily reshape a vessel, e.g. the inferior vena cava (“IVC”), in a single axis extending perpendicular to a longitudinal axis. The greater the expansion of the reshaping device, the greater the reduction in cross-sectional area and the greater the reduction in flow through the vessel. Modifying a blood flow to the heart as such can improve the symptoms of hypervolemia, leading to increased diuretic efficiency and improve symptoms of congestive heart failure.

1 . A blood flow regulating device for a vessel, comprising:
 a delivery catheter extending along a longitudinal axis; and   a vessel shaping device having a retracted configuration in the delivery catheter and an expanded configuration out of the delivery catheter, the vessel shaping device being arranged to expand to the expanded configuration along a transverse axis, perpendicular to the longitudinal axis of the delivery catheter, to reshape the vessel to a flattened configuration.   
     
     
         2 . The blood flow regulating device according to  claim 1 , wherein the flattened configuration of the vessel defines an extended transverse diameter, a reduced lateral diameter, and a smaller cross-sectional area than the cross-sectional area of the vessel in a resting configuration. 
     
     
         3 . The blood flow regulating device according to  claim 1 , wherein the vessel shaping device is self-expanding to the expanded configuration. 
     
     
         4 . The blood flow regulating device according to  claim 3 , wherein the vessel shaping device is formed from Nitinol. 
     
     
         5 . The blood flow regulating device according to  claim 1 , wherein the vessel shaping device comprises a frame including a first arm extending transversely outward from a central longitudinal axis to define a first apex, and a second arm extending transversely outward from a central longitudinal axis in an opposite direction from the first arm to define a second apex, a proximal end of the first arm and a proximal end of the second arm are coupled to a proximal collar, and a distal end of the first arm and a distal end of the second arm are coupled to a distal collar. 
     
     
         6 . The blood flow regulating device according to  claim 1 , wherein the vessel shaping device further comprises a tubular member coupled to the frame. 
     
     
         7 . The blood flow regulating device according to  claim 6 , wherein the tubular member is fixedly attached to a distal collar and slidably engaged with the proximal collar, the distal collar defining an atraumatic tip. 
     
     
         8 . The blood flow regulating device according to  claim 6 , wherein the tubular member is slidably engaged with a distal collar and fixedly attached to the proximal collar, a distal end of the tubular member defining an atraumatic tip. 
     
     
         9 . The blood flow regulating device according to  claim 1 , wherein movement of the tubular member or an actuator rod in one of a proximal direction or a distal direction further expands the vessel shaping device along the transverse axis. 
     
     
         10 . The blood flow regulating device according to  claim 1 , wherein the vessel shaping device further comprises a first stability member extending across the first apex from a proximal portion of the first arm to a distal portion of the first arm, and a second stability member extending across the second apex from a proximal portion of the second arm to a distal portion of the second arm. 
     
     
         11 . The blood flow regulating device according to  claim 10 , wherein the first stability member or the second stability member extends transversely inward towards the central longitudinal axis. 
     
     
         12 . A vessel shaping device, comprising:
 a tubular member extending along a longitudinal axis; and   a frame coupled to a distal end of the tubular member, the frame comprising:
 a first hinged arm including a first proximal member hingedly coupled to a first distal member to define a first apex, the first proximal member coupled to a proximal collar and the first distal member coupled to a distal collar; and 
 a second hinged arm including a second proximal member hingedly coupled to a second distal member to define a second apex, the second proximal member coupled to the proximal collar and the second distal member coupled to the distal collar. 
   
     
     
         13 . The vessel shaping device according to  claim 12 , wherein one of the proximal collar or the distal collar is threadably engaged with the tubular member. 
     
     
         14 . The vessel shaping device according to  claim 12 , wherein the proximal collar is threadably engaged with one of a right-hand thread or a left-hand thread and the distal collar is threadably engaged with one of a left-hand thread or a right-hand thread. 
     
     
         15 . The vessel shaping device according to  claim 12 , wherein rotation of the tubular member extends the first apex and the second apex away from a longitudinal axis along the transverse axis to transition the vessel shaping device to the expanded configuration. 
     
     
         16 . The vessel shaping device according to  claim 12 , further including a first apex member extending substantially parallel to the longitudinal axis and hingedly coupled to the first proximal member and the first distal member, and a second apex member extending substantially parallel to the longitudinal axis and hingedly coupled to the second proximal member and the second distal member. 
     
     
         17 . The vessel shaping device according to  claim 12 , further including a biasing member disposed between the proximal collar and the distal collar and configured to bias the vessel shaping device towards a retracted configuration. 
     
     
         18 . The vessel shaping device according to  claim 12 , further including a locking mechanism configured to releasably lock a proximal collar or a distal collar relative to the tubular member to inhibit longitudinal movement thereof. 
     
     
         19 . A method of regulating blood flow in a vessel, comprising:
 inserting a delivery catheter into the vessel;   moving a vessel shaping device out of a distal end of the delivery catheter; and   expanding the vessel shaping device from a retracted configuration to an expanded configuration along a transverse axis perpendicular to a longitudinal axis of the delivery catheter to reshape the vessel from a resting configuration to a flattened configuration.   
     
     
         20 . The method according to  claim 19 , further including advancing a tubular member distally relative to the deliver catheter to transition the vessel shaping device to the expanded configuration. 
     
     
         21 . The method according to  claim 19 , further including distally advancing an actuator rod relative to a tubular member to transition the vessel shaping device to the expanded configuration. 
     
     
         22 . The method according to  claim 19 , further including withdrawing a tubular member proximally relative to the deliver catheter, after moving the vessel shaping device out of a distal end of the delivery catheter, to transition the vessel shaping device to the expanded configuration. 
     
     
         23 . The method according to  claim 19 , further including rotating a tubular member relative to the deliver catheter to transition the vessel shaping device to the expanded configuration. 
     
     
         24 . The method according to  claim 19 , further including locking the vessel shaping device in the expanded configuration. 
     
     
         25 . The method according to  claim 19 , further including selectively detaching the vessel shaping device from the tubular member.